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Abstract of thesis entitled
“Implementation of video distraction to alleviate pain
of children during venipuncture”
Submitted by
Ku Sin Yin
for the degree of Master of Nursing
at The University of Hong Kong
in August 2014
Venipuncture of peripheral veins is a painful procedure commonly encountered by
pediatric patients during hospitalization. It causes physical consequences and
emotional distress of children, it also contributes to negative impact on future pain
responses, and therefore increases the difficulty of future care and the cost of care
(Bagnasco, Pezzi, Rosa, Fornoni & Sasso, 2012; Inal & Kelleci, 2012; Kennedy,
Luhmann & Zempsky, 2008; McCarthy & Kleiber 2006; McCarthy et al., 2010;
Srouji, Ratnapalan & Schneeweiss, 2010; Uman, Chambers, McGrath & Kisely, 2008;
von Baeyer et al., 2004; Yoo et al., 2008).
For the alleviation of pain of children during venipuncture, the implementation of
video distraction by using TV cartoon and animation movie was reviewed as an
effective distraction strategy in studies (Murphy, 2009; Uman et al., 2006). It diverts
children’s attention from a stressful situation and redirects their attention towards a
pleasant stimulus (McCarthy et al., 2010; Murphy, 2009; Uman et al., 2008).
According to the current practice of venipuncture in the targeted local paediatric unit,
there is neither evidence based guideline on interventions for pain management nor
guideline on practicing video distraction. Therefore, this paper aims at reviewing
evidence on the implementation of video distraction to alleviate pain of children
during venipuncture. In addition, a clinical guideline, an implementation plan and an
evaluation plan on implementing video distraction will also be revealed in this paper.
In this paper, critical appraisal on five selected studies, including four randomized
controlled trials and one quasi-experimental study were conducted with the
methodology checklist from Scottish Intercollegiate Guidelines Network (SIGN,
2013), and the four RCTs were of good quality. From the studies, video distraction
was reported as an effective intervention for relieving self reported pain, observational
pain, physiological pain responses of children and emotional distress during
venipuncture, and it also contributes to a higher success rate of venipuncture (Bellieni
et al., 2006; MacLaren & Cohen, 2005; Tak & van Bon, 2005; Wang et al., 2008; Yoo
et al., 2011).
In order to translate this effective intervention to the targeted clinical setting, an
implementation plan, which comprises a communication plan, a pilot study and an
evaluation plan, is established. With the implementation of video distraction during
venipuncture, reduction of pain of children and times of venipuncture was expected.
Implementation of video distraction to alleviate pain
of children during venipuncture
By
Ku Sin Yin
B.Nurs, RN
A dissertation submitted in partial fulfillment of the requirements for
the Degree of Master of Nursing
at the University of Hong Kong.
August 2014
i
Declaration
I declare that this thesis represents my own work, except where due acknowledgement
is made, and that it has not been previously included in a thesis, dissertation or report
submitted to this University or to any other institution for a degree, diploma or other
qualifications.
________________________________
Ku Sin Yin
August 2014
ii
Acknowledgement
I would like to express my sincere appreciation to my supervisor, Dr Chow Mei Kuen,
for her kind guidance and support on my dissertation. She has provided me a lot of
advices all along my dissertation. Without her support and inspirations, I could not be
able to finish my dissertation.
I would also like to express my gratitude to teaching staff of School of Nursing, The
University of Hong Kong, for their professional teaching and kind guidance in the
master course.
Thank you so much.
iii
Content
Declaration……………………………………………………………………………..i
Acknowledgement…………………………………………………………………….ii
Table of content………………………………………………………………………iii
Chapter 1: Introduction
1.1 Background………………………………………………………………………..1
1.2 Affirming the need………………………………………………………………...2
1.3 Objectives and significance………………………………………………………..5
Chapter 2: Critical appraisal
2.1 Search and appraisal strategies
2.1.1 Identification of studies……………………………………………………….... 7
2.1.2 Data extraction…………………………………………………………………..7
2.1.3 Appraisal strategy………………………………………………………………..8
2.2 Results
2.2.1 Search result……………………………………………………………………..9
2.2.2 Study characteristics……………………………………………………………10
2.2.3 Methodological issues………………………………………………………….12
2.3 Summary and synthesis
2.3.1 Summary of data……………………………………………………………….16
2.3.2 Synthesis of data………………………………………….…...……...……….. 20
Chapter 3: Translation and Application
3.1 Target setting……………………………………………………………………..23
3.2 Transferability of the findings……………………………………………………23
3.3 Feasibility………………………………………………………………………...26
3.4 Potential risks and benefits of the innovation……………………………………29
3.5 Evidence-based guideline.......................................................................................31
Chapter 4: Implementation Plan…………………………………………………..36
4.1 Identifying the stakeholders……………………………………………………...36
4.2 Communication Plan……………………………………………………………..37
4.3 Communication process and implementation strategies…………………………37
4.4 Pilot testing plan………………………………………………………………….38
4.5 Design of the pilot test…………………………………………………………...39
4.6 Subject recruitment………………………………………………………………39
4.7 Data collection……………………………………………………………………39
4.8 Review of guideline……………………………………………………………...40
4.9 Sustaining the change……………………………………………………………40
Chapter 5: Evaluation plan
5.1 Identifying outcomes…………………………………………………………….41
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5.2 Timing and frequency of data measurement……………………………………..43
5.3 Nature and number of clients to be involved ……………………………………43
5.4 Data analysis..……………………………………………………………………44
5.5 Evaluation on the effectiveness of change of practice…...………………………45
Chapter 6: Conclusion…………………………………..………..……...….…….. 46
Appendices
Appendix 1: Search process...………………….…………………………………… 47
Appendix 2: Table of evidence……………………………………………………... 48
Appendix 3: Quality Assessment of Selected Studies………….………..…….…… 52
Appendix 4: SIGN Methodological Quality Coding: Levels of Evidence…………..63
Appendix 5: Grades of Recommendations………………………….…….……..….. 64
Appendix 6: Venipuncture Record…………………………………………….……. 65
Appendix 7: Pain Scale....……………………………………………………………66
Appendix 8: Satisfactory Survey for Healthcare Providers…………………………. 67
References ………………………………………………………………..................68
1
Chapter 1 Introduction
1.1 Background:
Venipuncture is an invasive procedure which induces pain by puncturing with a
needle. Venipuncture of peripheral veins is commonly encountered by pediatric
patients during hospitalization, and it is one of the most fearful procedures in the
hospital stay (McMurtry et al., 2011). To alleviate pain of children during
venipuncture, video distraction was implemented and shown to be effective in studies
(Murphy, 2009).
It is important to control pain induced by venipuncture. Evidences show that
procedural pain contributes to psychological and physical consequences, such as
emotional distress and changes in heart rate, increase in blood cortisol level and blood
glucose level (Inal & Kelleci, 2012; Kennedy, Luhmann & Zempsky, 2008; McCarthy
et al., 2010; Srouji, Ratnapalan & Schneeweiss, 2010; Yoo et al., 2008). It also
negatively affects the future pain responses of children which causes unwillingness of
cooperation and increases the difficulty of future care, and it is even associat with
long-term consequences such as avoidance of health care in adulthood (Bagnasco,
Pezzi, Rosa, Fornoni & Sasso, 2012; McCarthy and Kleiber 2006; von Baeyer et al.,
2004). Since the alleviation of the procedural pain is associated with the ease of the
procedure in terms of time and success rates, the cost of care would also decrease
(Kennedy, Luhmann & Zempsky, 2008; Uman et al., 2008).
For the pain management of venipuncture, there are pharmacological and
non-pharmacological interventions. For pharmacological intervention, topical
application of eutectic mixture of local anesthetics (EMLA) cream is commonly used.
For non-pharmacological interventions, various choices are available for controlling
the pain such as distraction, imagery, hypnosis, breathing exercises, procedural
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education, positive reinforcement, etc., evidences show that distraction is an effective
strategy for pain management. (McCarthy et al., 2010; Murphy, 2009).
Distraction is a cognitive coping strategy which diverts children’s attention from a
stressful situation and redirects their attention towards a pleasant stimulus (McCarthy
et al., 2010; Uman, Chambers, McGrath & Kisely, 2008). It includes a passive
redirection of the child’s attention or an active involvement of the child with a task,
for example, listening to music or story via headphones, playing with toys, looking
through a kaleidoscope, playing games, watching a video, etc. (Kleiber & Harper,
1999; Murphy, 2009). The administration of distraction is safe, easy, and requires less
resources (McCarthy & Kleiber, 2006; Wang, Sun & Chen, 2008).
Murphy (2009) reviewed on distraction techniques for venipuncture and mentioned
that passive distraction by playing video had a positive effect in the alleviation of the
pain of children during venipuncture. For the videos used for distraction in the studies,
TV cartoon and animation movie were included (Murphy, 2009).
1.2 Affirming the need
In one of the pediatric wards of a local hospital, it consists of a general unit and a
pediatric intensive care unit (PICU). In the general unit, there are general pediatric
patients commonly admitted for fever, upper respiratory tract infections, chest
infection and gastroenteritis; there are also several specialties in the ward, including
neurosurgery, neurology and respiratory, patient are commonly admitted for head
injury, convulsion, preparation for investigation such as CT and MRI and
pre-operation preparation.
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Venipuncture on peripheral veins is usually performed for taking blood samples and
obtaining an intravenous (IV) access for administration of antibiotics, intravenous
fluid, anticonvulsants and sedation. According to the Phlebotomist record in the ward,
there are more than 1,000 patients requiring peripheral venipuncture from Jan to
mid-October in 2013 (Phlebotomist Record, 2013). Since venipuncture should be
done by medical officer, house officer and trained phlebotomist in the ward, the actual
number of patients required venipuncture may be underestimated.
Patients requiring venipuncture are usually brought into the treatment room by health
care staff, and no accompany of caregiver is allowed throughout the procedure.
Before venipuncture, explanation would be given to the patients and relatives about
the purpose and process of the venipuncture procedure, the level of cooperation of
patients would be assessed by nurses. If patients are likely to be uncooperative, before
the venipuncture, physical restrains are commonly applied by at least one health care
worker or nurse to restrict the movement of patients until the venipuncture finishes.
Even pain was observed from behavioral response or verbally expressed by the
patients during the procedure, no intervention for relieving the pain would be
provided. After the venipuncture, crying, fear of health care professionals and
uncooperative behavior in subsequent examinations and treatment procedures are
commonly observed.
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Venipuncture is one of the most common sources of pain in pediatric patients, the pain
induces psychological and physical impacts, which effects can be long-term (Inal &
Kelleci, 2012; McCarthy et al., 2010). For physical impacts, it causes the increase of
cortisol levels, and thus heart rate, cardiac output, and blood pressure (Inal & Kelleci,
2012; Kennedy, Luhmann & Zempsky, 2008; McCarthy et al., 2010; Srouji,
Ratnapalan & Schneeweiss, 2010; Yoo et al., 2008). For psychological impacts, it
causes emotional distress (Uman et al., 2013). To alleviate the pain due to
venipuncture is therefore necessary.
Although child response to the invasive procedure may be affected by preparation
given to them prior to the procedure, the provision of information and explanation
was shown to be not effective in the reduction of distress as children may not able to
process and remember information, especially for younger children (Jaaniste, Hayes
& von Baeyer, 2007; McCarthy et al., 2010). Besides, younger children present more
behavioural distress and pain during medical procedure (McCarthy et al., 2010), the
alleviation of pain among them would be even more essential.
Among various non-pharmacological interventions for relieving pain of pediatric
patients during painful procedures, distraction is the most commonly used strategy.
The effectiveness of pain relief is believed to be related to the limited capacity of
brain for focusing on stimulation, attention to the painful stimulus would be reduced if
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the attention is diverted to a distraction (Inal & Kelleci, 2012). For the distraction
method, audio-visual distraction was reported as one of the most effective
non-pharmacological interventions for pain relief, and watching a video of cartoon or
animation is suggested to be effective (Murphy, 2009; Uman et al., 2006).
Reviewing the current practice of venipuncture in the ward, there is no evidence based
guideline on interventions for the alleviation of pain during venipuncture nor
guideline on practicing distraction during venipuncture. Therefore, it may be possible
to apply distraction to make venipuncture a less painful procedure.
1.3 Objectives and Significance
As pain caused by venipuncture contributes to negative psychological and physical
consequences, and also negatively affect future pain responses and future care, to
alleviate pain caused by venipuncture is essential, especially for younger children. As
video distraction may be effective in reducing pain of paediatric patients caused by
peripheral venipuncture, a review on available evidences of video distraction for
alleviation of pain of children aged from 1 to 9, without developmental delay or visual
or auditory deficits during venipuncture was done with the following objectives:
1. To systematically review the current literatures on the effect of video distraction on
the alleviation of pain during venipuncture
2. To develop an evidence-based guideline for applying video distraction during
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venipuncture in the pediatric unit.
3. To develop strategies on the implementation of the evidence based guideline of
video distraction for patients in the pediatric unit.
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Chapter 2: Critical Appraisal
2.1 Search and Appraisal Strategies
2.1.1 Identification of studies
Studies were searched in three electronic databases, the Pubmed, CINAHL Plus
(EBSCOhost) and British Nursing Index (ProQuest), with the search terms including
‘needle’, ‘ IV access’, ‘IV cannulation’, ‘venipuncture’, ‘venipuncture’, ‘TV’,
‘audiovisual’, ‘Visual audio’, cartoon’ and ‘distraction’. During the searching process,
no restriction on the year of publication was applied. For studies which met the
selection criteria, 5 studies are available on Pubmed, 3 studies are available in
CINAHL Plus, and 2 studies are available in the British Nursing Index. However, the
studies from the three electronic databases were duplicated, therefore, only 5 studies
which met the selection criteria are available. The details of the searching process are
illustrated in Appendix 1.
For the inclusion criteria, randomized controlled trial (RCT) and quasi-experimental
studies done on pediatric patients of age from 1 to 9 were included. For the exclusion
criteria, articles which were not published in English and studies done on children
with developmental delay or visual or auditory deficits were excluded.
2.1.2 Data extraction
The 5 studies which met the selection criteria were selected as they met the inclusion
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criteria and did not meet any of the exclusion criteria. The details of the five studies
are presented in the tables of evidences, in which study design, evidence level, sample
size, subject characteristics, interventions, control, outcome measures, p value and
effect size are included. The tables of evidences are included in Appendix 2.
2.1.3 Appraisal strategy
To evaluate the quality of the selected five studies, critical appraisal of the studies
were conducted with the methodology checklist from Scottish Intercollegiate
Guidelines Network (SIGN, 2013). Studies with are rated as high quality and
indicated with ‘++’ in the table of evidence if a majority of the criteria in the checklist
were met, there was little or even no risk of bias, and further research did not likely
have differences compared to the result of the study. For studies which have most of
the criteria met, but some weaknesses were found to be related to the risk of bias, and
further studies may make differences from the conclusions of the study, they were
rated as acceptable and indicated with ‘+’. Studies were rated as low quality and
indicated with ‘0’, if the studies did not ever meet most of the criteria of the checklist
or had significant weaknesses that was associated with the main features of the study
design, and further studies probably make different conclusions. The critical appraisal
checklists of the five studies are included in Appendix 3.
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2.2 Results
2.2.1 Search result
Searching of evidences was done on 5th October, 2013, using the search terms and
electronic databases mentioned above. A total of 204 studies were available in
Pubmed by using the searching strategy as illustrated in Appendix 4. After screening
of titles and abstracts, and removal of duplication was done, there were only 8
potential studies left, other studies were excluded because the subjects of studies were
adult, the studies were focused on relieving pain during immunization, and the studies
were news. For the potential studies, after reading the full text, 3 studies were
excluded because the distraction method used in the study was not video distraction.
Therefore, only 5 studies met the selection criteria. In CINAHL Plus, using the same
searching strategy, there were only 3 studies available, other studies were excluded
because of the same reasons as mentioned above, in addition, two of the excluded
studies were published in Italian. In British Nursing Index, using the search terms of
‘needle’, ‘IV access’, ‘IV cannulation’, ‘venipuncture’ and ‘venipuncture’, a total of
464 studies was found, after narrowing the result by only including studies done on
children and pain, 28 results were available, after screening the title abstracts and
reading the full text, there were 2 studies left. However, the 3 available studies in
CINAHL Plus and the 2 available studies in British Nursing Index duplicated with the
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5 available studies in Pubmed. Therefore, there were 5 studies available for review as
shown in the tables of evidence.
2.2.2 Study Characteristics
In the 5 selected studies, there were four RCTs and one quasi-experimental study. The
studies were conducted in five different countries, including China, United States,
South Korea, Italy and Netherlands. There was no local study available. All of them
were single-center studies conducted in pediatric department, emergency room and
out-patient department. For the source of funding, the study of Wang et al.(2008)
declared no financial support, and the study of Maclaren & Cohen (2005) was
supported by a Routh Student Research grant, however, the source of financial
support was not mentioned in the other three selected studies (Bellieni et al., 2006;
Tak & van Bon, 2005; Yoo et al., 2011), About the subject characteristics, the age
range of children participating in the five studies were different from each other, the
study of Maclaren & Cohen (2005) and the study of Yoo et al. (2011) were done with
younger children of age under 7, but the age of study populations of the five studies
was within the range of 1 to 12 as presented in the tables of evidence in Appendix 2.
For the interventions, either cartoon or animation was used for distraction in the
intervention groups in the five studies, but they were not the only intervention group
for comparison, in the studies except the study of Yoo et al.(2011). The active
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distraction by mother, interactive toy, provision of information, ELMA cream and
psychological intervention were also arranged in another intervention group for
comparison with the control group in the other four studies (Bellieni et al., 2006;
Maclaren & Cohen, 2005; Tak & van Bon, 2005; Wang et al., 2008). For the control
groups, no distraction was provided in all studies. For the outcome measures, apart
from pain rated by children, pain of children rated by caregiver and nurses and child
distress, including pain as one of the components, behavioral pain responses, child
engagement in distraction, cooperation, venipuncture times, and even physical
parameters including blood cortisol level blood glucose level and heart rate were also
included as outcome measures in the five selected studies (Bellieni et al., 2006;
Maclaren & Cohen, 2005; Tak & van Bon, 2005; Wang et al., 2008; Yoo et al., 2011).
As pain scales were used for evaluation of pain responses, mean pain score were
reported in every study, calculation of Cohen’s d was used for the calculation of effect
size. After calculating the effect size of the studies, medium to large effect size was
noted in 4 studies with Cohen’s d from 0.5 to 0.9, and small effect size was noted in
the study of Wang et al.(2008) with Cohen’s d of 0.3. About the significance, the p
value of the four studies ranged from less than 0.01 to 0.047 (Bellieni et al., 2006;
Maclaren & Cohen, 2005; Wang et al., 2008; Yoo et al., 2011). Though the p value
was not reported in the study of Tak & van Bon (2005), the study showed moderate
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effect of video distraction on the alleviation of pain of children during venepuncture.
2.2.3 Methodological issues
After assessing the quality of the selected studies with the checklist of SIGN(2013),
the study of Wang et al., (2008) was rated as good quality and was indicated with ‘++’,
the study of Yoo et al. (2011) was rated as low quality and was indicated with ‘0’, and
the quality of the studies of Bellieni et al. (2006), MacLaren & Cohen (2005), Tak &
van Bon (2005) were rated as acceptable and where indicated with ‘+’. The Wang et al.
(2008) was rated as good quality because it fulfilled the majority of the criteria listed
in the checklist, the other three RCTs were rated as acceptable because some
limitations were found. The methodological issues of the studies are going to be
discussed.
In all of the selected studies, clear research questions were clearly mentioned in each
study. About the random assignment of study participants, except the study of Yoo et
al. (2011) which is a quasi-experimental design, all the other four studies are RCTs. In
the study of Bellieni et al. (2006) and the study of Wang et al. (2008), study
participants were randomly assigned to different groups according to the random
number sequence generated by the computer, and the sequence of number was
specifically generated with Research Randomizer in the study of Wang et al. (2008).
In the study of MacLaren & Cohen (2005), children were randomly assigned to the
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movie distraction group, interactive toy group and control group on alternate bases.
For the concealment method, out of the five studies, the study of Wang et al., (2008)
was the only study that applied concealment with sealed envelopes. However, both
blinding of study participants and investigators about the allocation of treatment were
not possible due to the nature of the studies, which were also reported the studies
(Bellieni et al., 2006; Maclaren & Cohen, 2005; Tak & van Bon, 2005; Wang et al.,
2008; Yoo et al., 2011).
About the subject characteristics of the treatment groups and the control group, a
comparison was done in each study. In the study of Yoo, et al. (2011), subject
characteristics of the intervention group and the control group were similar except for
the age, 5 more patients in the experimental group were between 5 to 7 years old
while 5 more patients in the control group were between 37 and 48 months old, the
difference of age was significant with the p value of 0.046, and the age of children in
the experimental group was greater than those in the control group by 10.5 months. In
the other four studies, comparing the intervention group and the control group, no
significant difference of the subject characteristics was noted before the trial started. ).
In the study of Bellieni et al. (2006) and the study of Wang et al. (2008), simple
figures and percentage were listed in tables for comparison of subject characteristics
respectively. In the study of MacLaren & Cohen (2005), Chi-square analyses and
14
analyses of variance (ANOVAs) were used to investigate for any significant
differences between groups in terms of subject characteristics, while F-values and
Chi-square analyses were applied in the study of Tak & van Bon (2005).
In all of the studies, details of interventions were clearly mentioned, whereas no
additional intervention was applied to the intervention group or the control group
which may cause bias.
For the measurement of outcomes, pain of children during venipuncture was assessed
with Oucher scale in the studies of Bellieni, et al. (2006) and Tak & van Bon (2005).
Oucher scale was a widely used scale for assessment of pain in children, the
application of the scale for children aged 3 years old or above are suitable, and its
validity was supported by evidences. (Beyer, Turner, Jones, Young, Onikul & Bohaty,
2005; Tomlinson, von Baeyer, Stinson & Sung, 2010) As the age of subjects were from
3 to 12 in the study of Tak & van Bon (2005), and children in the study of Bellieni et al.
(2006) were aged between 7 and 12, Oucher scale was valid for both studies. In the
study of Wang et al., (2008), Visual Analog Scale (VAS) was used. Evidences
reviewed VAS as a valid tool for self-reported pain of children from the age of five,
as the subjects in the study of Wang et al. (2008) were aged from 8 to 9, VAS was a
valid scale for the study (Crellin, Sullivan, Babl, O'Sullivan, & Hutchinson, 2007;
Tomlinson, von Baeyer, Stinson & Sung, 2010). In the study of Yoo, et al. (2011),
15
5-point Poker Chip Scale was used for self- reported pain of subjects aged 4 or above,
and Faces Rating Scale of Wong and Baker (1988) was used for behavioral pain
responses, both scales were reviewed as preferable and valid (Tomlinson, von Baeyer,
Stinson & Sung, 2010). For the assessment of distress, Observation Scale of
Behavioral Distress (OBSD) was used in the study of MacLaren & Cohen (2005), the
validity of the scale was widely proved (Crellin, Sullivan, Babl, O'Sullivan,
& Hutchinson, 2007).
In all studies, the drop-out rate was 0%, and intention to treat analysis was conducted.
However, in the study of MacLaren & Cohen (2005), missing of data was noted due
to due to equipment or human errors. 12.9% of the patients aged 4 to 7 involved in did
not self-report their post-procedural distress, and 6.8% of patients did not have video
data for coding for Child observational distress, child engagement in distraction, nurse
distraction, or care giver distraction. The data were considered as missing data which
did not have any compensatory actions.
In conclusion, the four RCTs fulfilled most of the criteria included in the checklist of
SIGN(2013), while the study of Yoo, et al. (2011) have more methodological
limitations in terms of randomization, concealment, blinding, small difference in
subject characteristics between intervention group and control group. Therefore, the
study of Yoo et al. (2011) was rated as poor quality, while others were in acceptable to
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good quality.
2.3 Summary and Synthesis
2.3.1 Summary of data
All the five studies fulfil the selection criteria, there were patients within the age
range of 1 to 9 who required venipuncture, and no patient in the selected studies met
any of the exclusion criteria including developmental delay, visual or auditory deficits,
or altered mental status.
In the five studies, the outcome measures were pain rated by children, pain of children
rated by observers, including caregiver and nurses, child distress including pain as one
of the components, behavioral pain responses, children’s engagement in distraction,
cooperation, times of venipuncture, blood cortisol level, blood glucose level and heart
rate (Bellieni et al., 2006; MacLaren & Cohen, 2005; Tak & van Bon, 2005; Wang et
al., 2008; Yoo et al., 2011).
Pain rated by children was included in four studies, including the studies of Bellieni et
al., (2006), Wang et al. (2008), Tak & van Bon (2005) and Yoo et al. (2011). The
effectiveness of video distraction on relieving self-reported pain was supported with
significant results. Significance was shown in the studies of Bellieni et al.(2006),
Wang et al. (2008) and Yoo et al. (2011), with the p value of 0.037, 0.047 and 0.029
respectively. The p value was not mentioned in the study of Tak & van Bon (2005),
17
but the study showed a moderate effect (Cohen’s d = 0.5) of video distraction on
reducing self-reported pain. In addition, the strong effect size of video distraction was
shown in the studies of Bellieni et al. (2006) and Yoo et al. (2011), with Cohen’s d
equals to 0.77 and 0.72 respectively. Apart from self-reported pain, pain rated by
caregivers and behavioral pain responses were also under investigation (Bellieni et al.,
2006; Yoo et al., 2011). Video distraction was significant in relieving the pain of
children rated by caregivers in the study of Bellieni et al. (2006), with significant p
value 0.045 and moderate effect size with Cohen’s d equals to 0.6. Furthermore, in the
study of Yoo et al. (2011), statistical significance was shown in reducing the
behavioral pain response observed, the p value was 0.002, and the effect size was up
to 1.02. The study of Maclaren & Cohen (2005) also showed significant results in
reduction of distress reported by children and distress reported by caregiver, with pain
as one of the components of distress, and faces pain scales and VAS were used, the p
values were less than 0.01 and the effect sizes were strong with Cohen’s d equals to
0.7 and 0.9. From the physiological responses, including increase of blood cortisol
level, blood glucose level and heart rate investigated in the study of Yoo et al. (2011),
although there is no significant difference in heart rate between the video distraction
group and the control group, there were significantly lower blood cortisol level and
glucose level in the video distraction group compared to the control group (Yoo et al.,
18
2011), hence, the video distraction was also effective in reducing the physiological
response. According to studies, changes in heart rate, increase in blood cortisol level
and blood glucose level have positive associations with pain (Inal & Kelleci, 2012;
Kennedy, Luhmann & Zempsky, 2008; McCarthy et al., 2010; Srouji, Ratnapalan &
Schneeweiss, 2010; Yoo et al., 2008). Therefore, video distraction is an effective
intervention for relieving self reported pain, observational pain, and also physiological
pain responses of children during venipuncture with evidences support, according to
the selected studies (Bellieni et al., 2006; MacLaren & Cohen, 2005; Tak & van Bon,
2005; Wang et al., 2008; Yoo et al., 2011).
Children distress during venipuncture was under investigation in the studies of
MacLaren & Cohen (2005) and Tak & van Bon (2005). The response of distress
mentioned in the two studies included crying, screaming, breathing, increased rigidity
of muscle, flail, verbal fear and resistance to the procedure, looking for emotional
support and verbal pain (MacLaren & Cohen, 2005; Tak & van Bon, 2005). Though
the results of the two studies did not reach statistical significance which may be due to
the small sample size of the study. Both the study of MacLaren & Cohen (2005) and
the study of Tak & van Bon (2005) showed a moderate effect size of video distraction
on reduction of observational distress in children during venipuncture and just before
venipuncture respectively, both with Cohen’s d of 0.5.
19
The outcome measure of engagement of child in distraction was only included in the
study of MacLaren & Cohen (2005) out of the five studies. With the p value less than
0.01, the study showed that children in the video distraction group were significantly
more engaged in the distraction comparing to the children in interactive toy group and
the control group (MacLaren & Cohen, 2005). From the correlations conducted in the
study, it showed that more engagement was related to less distress in children during
venipuncture (MacLaren & Cohen, 2005). Therefore, the promotion of engagement of
children in the distraction strategy would reduce the distress of children during
venipuncture.
Cooperation and times of venipuncture were only under investigation in the study of
Wang et al. (2008). In terms of the number of times of venipuncture, higher successful
rate was noted in the video distraction group at the first attempt of venipuncture, in
comparison to the control group (Wang et al., 2008). Video distraction has a
significant effect on the number of attempts required for successful venipuncture
when compared to the control group, with the p value less than 0.05 (Wang et al.,
2008). However, in terms of cooperation, there was no statistical difference between
the video distraction group and the control group (Wang et al., 2008).
In conclusion, video distraction is effective in reducing the pain of children during
venipuncture (Bellieni et al., 2006; MacLaren & Cohen, 2005; Tak & van Bon, 2005;
20
Wang et al. (2008); Yoo et al., 2011), it also has a positive effect in reduction of
distress which may be due to the engagement of children in distraction (MacLaren &
Cohen, 2005; Tak & van Bon, 2005). In addition, it has a positive effect on the
successful rate of venipuncture (Wang et al., 2008).
2.3.2 Synthesis of data
To apply the video distraction in the pediatric unit, target population should be
identified. With reference to the inclusion criteria and exclusion criteria of the
selected studies, children who are in the age range from 1 to 9 and require
venipuncture would be included, for children who have experienced venipuncture
within 3 months, with self-reported pain or pain as assessed by nurses, diagnosis of
developmental delay, visual or auditory deficits, or altered mental status such as
sedated patients, patients with post-ictal drowsiness and comatosed patients, they
would be excluded (Bellieni et al., 2006; MacLaren & Cohen, 2005; Tak & van Bon,
2005; Wang et al., 2008; Yoo et al., 2011). For children who meet the inclusion
criteria and do not have any of the exclusion criteria, the application of video
distraction should not have any contraindication, and none was reported in the studies
(Bellieni et al., 2006; MacLaren & Cohen, 2005; Tak & van Bon, 2005; Wang et al.,
2008; Yoo et al., 2011).
For the choices of video for distraction, the selection should be age appropriate as
21
stressed in the studies of Bellieni et al., (2006) and MacLaren & Cohen (2005). In
addition, choices of video should be provided to patient to select according to their
interests, as their preferences on video may be different according to their age and
gender, or simply personal interests, the cartoon may be provided for younger
children and animation movie may be a suitable choice for older children (MacLaren
& Cohen, 2005; Wang et al., 2008). From the studies, cartoon or animation used for
distraction was played in English, to apply in the local pediatric unit, choices of video
of different language including Cantonese, English and Mandarin should be provided.
To have successful distraction, video played should be able to gain their interest in
order to divert their attention from venipuncture.
For the time of initiation of video distraction, it should be started at least 2 minutes
before starting venipuncture according to the studies (Bellieni et al., 2006; MacLaren
& Cohen, 2005; Wang et al., 2008). Moreover, the distraction should be conducted
continuously throughout the whole process of venipuncture until the procedure
finished for continuity of distraction.
About the equipment required, as suggested in the studies, DVD players could be
used for playing videos for distraction (MacLaren & Cohen, 2005; Wang et al., 2008),
which are already available in the pediatric unit.
From the study of MacLaren & Cohen (2005), engagement in distraction is an
22
important factor for distress rated by children. To ensure engagement, the
environment may be important. For the location, the venipuncture can still be
performed in the treatment room in order to provide a quiet environment for the
implementation of video distraction. In a quiet environment, environmental stimulus
would be reduced, the engagement and adherence of children to the video distraction
would be promoted.
Presence of caregiver during venipuncture may be helpful, with no active distraction
from the caregiver required, the presence of the caregiver may promote the adherence
of children to the video and therefore increasing the engagement in the video
distraction (Bellieni et al., 2006; MacLaren & Cohen, 2005).
In conclusion, to reduce pain of children during venipuncture, video distraction
should be applied to children of age between 1 and 12. The intervention should be
conducted in the treatment room and started at least 2 minutes before venipuncture,
moreover, various choices of video should be provided and chosen according to
patient’s interest.
23
Chapter 3: Translation and Application
The previous chapter demonstrated that the implementation of video distraction
during venipuncture, with the use of cartoon and animation, is effective in alleviation
of self-reported pain, observational pain, physiological response and observational
distress of pediatric patients aged from 1 to 12 (Bellieni et al., 2006; MacLaren &
Cohen, 2005; Tak & van Bon, 2005; Wang et al., 2008; Yoo et al., 2011). In addition,
it has a positive effect on the success rate of venipuncture (Wang et al., 2008).
In this chapter, the application of video distraction for alleviation of pain of children
during venipuncture in the target clinical setting would be illustrated.
3.1 Target setting
The intervention could be considered to be implemented in the pediatric unit of a
public hospital in Hong Kong. The target patients would be pediatric patients of age 1
to 9 admitted to the unit, who are in need of venipuncture.
To estimate the implementation potential, the transferability of the findings, feasibility
of the intervention and cost-benefit ratio of the innovation would be assessed.
3.2 Transferability of the findings
For the characteristics of the target population, the intervention would only be applied
to patients without any diagnosis of developmental delay, visual or auditory deficits,
or altered mental status, such as confused, sedated, comatose, etc., as none of the
24
selected studies were done on patients with the above characteristics, the
characteristics of the study participants were similar to the target population.
For the issue of age range, the subjects of the selected studies were pediatric patients
with an age range from 1 to 12, while the age range of the target patients in the
pediatric unit would be from 1 to 9. For the gender, there was no significant
difference in gender of participants in the selected studies. The gender distribution of
patients requiring venipuncture in the proposed unit is unknown, since venipuncture
can be done by phlebotomists, houseman, doctors and nurses, venipuncture could be
done without recording in the Phlebotomist record. However, it is unlikely to have a
great difference in gender as the patients in the proposed unit were mostly admitted
for infections. Therefore, in terms of age and gender, the population of selected
studies is similar to those of target setting.
Although three selected studies were conducted in out-patient departments (Bellieni et
al., 2006; MacLaren & Cohen, 2005; Tak & van Bon, 2005), one was conducted in the
emergency room (Yoo et al., 2011), and only one was conducted in the pediatric
department (Wang et al., 2008), as all participants of the selected studies were
children having venipuncture, in terms of patient characteristics and procedure, the
studies were similar to the target setting, the implementation of the intervention in a
pediatric unit should be transferable.
25
Besides, the philosophy of care of the innovation is consistent with the philosophy of
care of HA. The implementation of the video distraction with cartoon or animation
during venipuncture is mainly for the alleviation of procedural pain caused by
venipuncture, and therefore its psychological and physical consequences (Inal &
Kelleci, 2012; Kennedy, Luhmann & Zempsky, 2008; McCarthy et al., 2010; Srouji,
Ratnapalan & Schneeweiss, 2010; Yoo et al., 2008). The Hospital Authority (HA)
requires nurses to be competent in providing holistic caring service, and to provide
people-centered care is the value of HA (HA, 2006; HA, 2013). With a caring heart,
to implement the intervention and reduce the pain and the corresponding
psychological and physical impact is a way to practice the value of HA.
The proposed innovation would benefit a number of patients in the target setting.
According to the Phlebotomist record in the ward, there are more than 1,000 patients,
aged 1 to 9, and undergone peripheral venipuncture from Jan to mid-October in 2013
(Phlebotomist Record, 2013). As the characteristics of patients admitted to the unit in
the following year would be similar in terms of age and diagnosis, the reasons of them
require venipuncture would also be similar, there would be still quite a number of
patients benefiting from the innovation.
To test the transferability, a pilot test would be conducted in the target clinical setting.
The estimated time for implementation and evaluation of the proposed innovation will
26
be around one year. First, assessment of the available cartoon and animation DVDs
will be done, and funding will be applied for purchasing DVDs of cartoon or
animation. Although there are already DVD players and some cartoon or animation
DVDs available from the play therapist in the department, as the targeting children are
of age from 1 to 9, the available DVDs of cartoon or animation may not be suitable
for targeting children of different age, a larger variety of choices may be necessary.
When DVDs are available, briefing sessions and the guideline of the proposed
intervention will be provided to all related staff before commencing the intervention.
About one month after the end of all briefing sessions, all related staff should be able
to familiar with the intervention, and data collection will then be started. The data
collection period would be around half year, and then the evaluation would be
conducted. The estimated time of one-year is reasonable for implementing the
intervention and evaluating its efficacy.
3.3 Feasibility
In the proposed setting, nurses are able to implement evidenced based innovation with
the approval of the ward manager (WM) and the department operations manager
(DOM), they are also able to terminate the innovation if it is evaluated to be
ineffective or inapplicable. Therefore, administrative support is important. In the
pediatric department of the proposed unit, nurses are encouraged to take part in
27
evidence based studies sharing and launch a new practice with evidence support. In
the past few years, at least one innovation or amendment of practice was commenced
each year. The climate of the proposed unit is supportive of the implementation of the
intervention.
Apart from the administrative support, the support of all related staff, including
Phlebotomist, nurses, doctors and supporting staff is also important. The significance
and effectiveness of the intervention and the workload would be introduced to them in
order to gain their consensus. Therefore, the briefing sessions of evidence-based
guideline is important for convincing the staff. Other than the significance and the
effectiveness of video distraction for alleviation of pain during venipuncture, the
workload for implementing the intervention may be a more important concern to staff.
Extra time may be needed for preparing the video, for example, time for patients to
select cartoon or animation to be watched during the venipuncture procedure, and to
start the video at least two minutes before venipuncture. However, the intervention
would not be time consuming if the staff doing the venipuncture doing preparation for
the procedure while the supporting staff preparing the video for the patient. In fact,
the extra time used should not be long and cause interference to their work. For the
manpower, no extra manpower would be needed. Therefore, there should not be a
great increase of workload in terms of manpower and time consumption, the support
28
of staff should be available.
For the equipment, DVD players and DVDs of cartoon and animation are already
available in the unit. In order to implement the intervention, we only need to increase
the variety of cartoon or animation for children of different ages and speaking
different languages. As most of the patients in the unit speak Cantonese or English,
the preparation would not be difficult.
To implement the intervention, staff should be able to identify target population and
practice the distraction according to the guideline. Therefore, the inclusion and
exclusion criteria of the target population, the guideline of the intervention, the
operation of the DVD player will be explained in briefing sessions. In addition, the
evaluation method will also be explained. Briefing sessions will be arranged in
separate days in the ward, 30 minutes before the handover of shifts, so as to facilitate
more related staff to attend the sessions. The duration of a briefing session, which
lasts for 30 minutes, should be reasonable, staff may be willing to join the session
during work or before work.
For the evaluation, Visual Analog Scale used in selected studies, would be used for
assessment of pain (Bellieni et al., 2006; MacLaren & Cohen, 2005; Tak & van Bon,
2005; Wang et al., 2008; Yoo et al., 2011). Assessment would be done by nursing
staff, as both scales are already currently used scales, no extra training and materials
29
would be needed.
In conclusion, with the approval of administrative staff, the support and joint effort of
frontline staff, and the availability of equipment, it is feasible to implement the
innovation in the target clinical setting.
3.4 Potential risks and benefits of the innovation
Concerning the cost-benefit ratio of the implementation of the intervention, the
potential risks, benefits and costs including the material and non-material costs will be
reviewed.
To the patients, according to the selected studies, no risk nor incident was reported
(Bellieni et al., 2006; MacLaren & Cohen, 2005; Tak & van Bon, 2005; Wang et al.,
2008; Yoo et al., 2011). For the potential risk of the implementation of the
intervention without using any analgesics, experience of pain due to venipuncture by
children can be anticipated. However, there are several potential benefits resulting
from the implementation of the innovation as supported by the selected studies,
including the reduction of pain, distress and the successful rate of venipuncture
(Bellieni et al., 2006; MacLaren & Cohen, 2005; Tak & van Bon, 2005; Wang et al.,
2008; Yoo et al., 2011).
For the cost, in the short term, the material cost would be mainly from purchasing the
DVDs. As there are already some cartoon and animation DVDs available in the unit,
30
and some of them are bilingual, it is not necessary to purchase a large number of
DVD for the provision of sufficient choices. As the price of cartoon or animation
DVD are mostly around $150, the material cost is estimated to be around $1000. In
the long run, as the maintenance cost of DVD players is already the general
expenditure of the unit, there is no extra maintenance cost added to the
implementation of innovation.
For the nonmaterial cost, it would be the time spent on the briefing sessions, the time
for the evaluation of the innovation and also the anticipated stress of staff for
changing of usual practice.
However, without trying the innovation, by continuing the current practice of
explaining the procedure to children and applying physical restrain, there would not
be any improvement in alleviating the procedural pain and the corresponding physical
and psychological consequences, including the physiological responses and distress
(Inal & Kelleci, 2012; Kennedy, Luhmann & Zempsky, 2008; McCarthy et al., 2010;
Srouji, Ratnapalan & Schneeweiss, 2010; Yoo et al., 2008). As the intervention may
be effective in increasing the success rate of venepuncture. In terms of material
benefits, less consumables such as angiocatheter and alcohol pad will be used for the
procedure. In terms of non material benefits, time for venepuncture may be saved as
the success rate increases, in addition, staff morale may be improved because of the
31
satisfaction and also the saving of physical energy for restraining the patient.
As the intervention may contribute to better patient outcome, outweighing the cost
and benefit, the implementation may result in a reduction of health care cost.
In conclusion, the implementation of the innovation is transferable, feasible and
beneficial to the proposed unit. Therefore, an evidence based guideline is proposed
with the support of the selected studies.
3.5 Evidence-based guideline
From the previous section, it illustrated that there is potential for implementing the
intervention in the targeting pediatric unit. An evidence-based guideline is generated
based on the level of evidence and the grades of recommendations from the Scottish
Intercollegiate Guidelines Network (SIGN), with the level of evidence indicated by
1++, 1+, 1-, 2++, 2+, 2-, 3 and 4 as shown in Appendix 4, and the grades of
recommendations indicated by A, B, C, and D as shown in Appendix 5 (SIGN, 2012).
Title:
Implementation of video distraction to alleviate pain and distress of children during
venipuncture
Objectives of the evidence-based guideline:
The objectives of this guideline are
1. to review the evidence from the selected studies for the alleviation of pain and
32
distress of children during venipuncture with video distraction
2. to generate an evidence based instructions for the implementation of video
distraction during venipuncture
3. to alleviate pain of children during venipuncture by implementing video
distraction
Target group:
The guideline is for supporting nurses in making the decision for the implementation
of video distraction during venipuncture.
Recommendations:
1. Patient Characteristics
Recommendation 1.1 (Grade A)
Patients are likely to benefit from video distraction during venipuncture if they are
aged between 1 and 9.
Evidence:
Patients of age 1 to 7 were distracted with videos of cartoon and animation and were
less distress (MacLaren & Cohen, 2005)(1+).
Video distraction was effective in the reduction of pain and increasing the successful
rate of venipuncture on patients aged between 8 and 9 (Wang et al., 2008) (1++).
Recommendation 1.2 (Grade A)
33
Patients are likely to benefit from video distraction during venipuncture if they have
no altered mental status, such as sedated and confused, or developmental delay in
cognition or visual or auditory senses.
Evidence: Patients benefiting from the distraction in the study have no history of
cognitive developmental delay, visual, auditory deficit, altered mental status or had
treatment of narcotic analgesics (Wang et al., 2008; Yoo et al., 2011) (1++; 2+)
Recommendation 1.3 (Grade A)
Patients are likely to benefit from video distraction during venipuncture if they have
no history of venipuncture within the past 3 months and frequency of venipuncture
more than once per year.
Evidence:
Patients benefiting from the distraction in the study have no history of venipuncture
within the past 3 months. (Wang et al., 2008) (1++)
Patients benefiting from the distraction in the study have no history of frequent
venipuncture for more than once per year. (Bellieni et al., 2006) (1+)
2. Initiation and duration of the intervention
Recommendation 2.1 (Grade A)
Video of cartoon or animation for distraction should be started at least 2 minutes
before starting venipuncture.
34
Evidence: In the studies, the video of cartoon or animation had started for at least 2
minutes before venipuncture performed (Bellieni et al., 2006; MacLaren & Cohen,
2005; Wang et al., 2008) (1+; 1+; 1++)
Recommendation 2.2 (Grade A)
The video of cartoon or animation should be continue throughout the process of
venipuncture.
Evidence: Engagement in the distraction is important for distress rated by patients
(MacLaren & Cohen, 2005). (1+)
3. Choices of video
Recommendation 3.1 (Grade A)
Age appropriate animation or cartoon should be used. Cartoon may be provided for
younger children while animation for older children
Evidence: The distraction should be age appropriate in order to be effective (Wang et
al., 2008). (1++)
Recommendation 3.2 (Grade A)
Patients should be provided with choices of video of cartoon or animation before the
initiation of the distraction.
Evidence: Engagement in the distraction is important for distress rated by patients
(MacLaren & Cohen, 2005). (1+)
35
4. Environment
Recommendation 4.1 (Grade A)
Venipuncture should be performed in the treatment room which is a quiet
environment for engagement and adherence to the distraction.
Evidence: It is important to ensure patients were engaging and adhering to the
distraction, as the increase of engagement in distraction is related to the reduction of
distress of patients (MacLaren & Cohen, 2005). (1+)
To apply the guideline in the proposed unit, a pilot test scheme will be conducted.
There will be four steps of the scheme including the application of approval and
necessary resources from the administrative staff, the provision of training to frontline
staff, the implementation of the guideline and the evaluation, every step will last for
one month. For evaluation, pain score of children during venipuncture, the success
rate of venipuncture and staff satisfaction will be assessed. The implementation plan
of the guideline will be further discussed in the next chapter.
36
Chapter 4: Implementation Plan
After developing the evidence-based guideline, to effectively implement the
evidence-based guideline in the target clinical setting, the implementation plan
comprises the communication plan with potential users and the pilot study plan will
be commenced.
4.1 Identifying the stakeholders
To obtain support from the stakeholders is essential for the implementation of the
guideline. Stakeholders are the administrators, physicians, Advance Practice Nurses
(APNs), Registered Nurses (RNs), phlebotomists and health care assistants.
The administrators, including the Department Operation Manager (DOM) and the
Ward Manager (WM) are responsible for approving the proposed implementation,
providing the necessary resources for commencement of the guideline, and also
arranging duty roster for nurses and health care assistance for attending training
sessions before implementation of the guideline.
Frontline staff including RNs, house officers, medical officers, phlebotomists and
health care assistances, who involve in the process of venipuncture, are potential users
of the implementation. In addition, the APNs are responsible for monitoring and
providing assistance in the implementation process. Their cooperation and compliance
are essential for the implementation of the guideline.
37
4.2 Communication Plan
Communication with the stakeholders will be started from the administrative level.
The implementation will be introduced to the WM, and a meeting with WM and
DOM will be held to present on the intervention. After gaining their approval, APNs
will be approached; a 15 minute presentation will be given to them during handover
time in order to introduce the intervention to them and gain their support. Finally,
identical sessions of presentation about the significance and benefit of implementation,
and the detail of the implementation guideline will be arranged with the frontline
staff.
4.3 Communication process and implementation strategies
To initiate the implementation, to obtain approval and necessary resources from the
DOM and WM of the target unit is essential. A proposal with a presentation regarding
the significance and benefits of the implementation will be provided to administrators
with evidentiary support. In addition, the implementation guideline, estimated
manpower and the necessary resources will also be included in the presentation.
After the guideline is endorsed and resources available, APNs will be invited to be
coordinators of the implementation program, and be responsible for monitoring and
providing assistance for the implementation, in order to maintain the compliance of
frontline staff to the guideline.
38
To enhance the willingness of frontline staff to implement the guideline and their
compliance to the guideline, training sessions will be provided. To ensure all potential
users are able to receive the training. Identical sessions of training, each last for
30minutes, will be arranged in ward 30minutes before the start of P shift in 3 weeks.
At each training session, a presentation about the significance and benefit of
implementation, the detail of the implementation guideline, choices of video available,
operation of the DVD player and data collection method for evaluation will be
provided. In addition, the soft copy of the guideline will be sent to all potential users
via intranet email for reference. Hardcopies of the guideline will also be available at
nursing station and the treatment room where venipuncture usually undergoes in.
After all training sessions completed, the pilot scheme will be started and lasted for
one month. After the evaluation is completed, the results will be disseminated to
DOM and WM.
4.4 Pilot testing plan
To test the feasibility and acceptability of the implementation, and to examine the
effectiveness of the guideline, a pilot scheme will be commenced in the pediatric unit.
Evaluation will be done at the end of the pilot scheme to review the process of the
implementation of the guideline, and to look into any unexpected difficulty and
problems during the implementation, so as to modify the guideline and facilitate the
implementation of the new guideline in the future. The detail of the pilot test is
39
included in the following paragraphs.
4.5 Design of the pilot test
A 3-month pilot test plan will be launched in the target pediatric unit. After a 3-week
training period, front line staff will participate in a randomized control trial of the
implementation which lasts for 4 weeks. Following the implementation period,
evaluation will last for 4 weeks.
During the implementation period, RNs who completed the training are in charge of
the patient requiring venipuncture would pick a sealed envelope in the nursing station
to randomly assign the patient in the intervention group or the control group. Patients
in control group would receive usual care while patients in intervention group would
receive video distraction in accordance with the guideline.
4.6 Subject recruitment
Subject recruitment will be done by RNs as case nurses are familiar with their
patient’s demographic data and medical history, and thus be able to determine
whether the patients are eligible to participate in the study according to the guideline.
Approximately a total of 60 subjects would be included.
4.7 Data collection
Pain score would be assessed by the RN participates in venipuncture procedure and
recorded in the log book with the subject’s demographic data, size of cannula used,
40
the times of venipuncture and any adverse events right after the procedure. Visual
Analog Scale (VAS) and Faces Legs Activity Cry Consolability Pain Scale (FLACC)
would be used, training sessions would be provided for nurses to revise on how to
assess pain with the pain scales. As coordinators, APNs would monitor the
compliance of staff in doing the assessment and the documentation of data, and also
provide support of any difficulty encountered.
Besides, opinion would be collected from frontline staff and APNs by collecting
evaluation forms in a box located in the nurse’s station during the pilot test period, in
order to collect data on their acceptability, level of workload, compliances and any
advices for the implementation. Meetings will also be conducted in the ward once a
week to discuss on the difficulty encountered during the implementation and gaining
feedbacks from the users.
4.8 Review of guideline
After the implementation period, the logbook and opinion forms from staff would be
collected for evaluation. After the evaluation, the implementation guideline will be
modified according to the data collected.
4.9 Sustaining the change
With the result of the evaluation, the evaluation report and the modified guideline will
be handed in to WM and DOM, and their approval of the implementation of the
41
modified guideline in the proposed unit will be applied.
Chapter 5: Evaluation plan
Evaluation of the guideline is essential to review on its effectiveness and benefit to the
outcomes of patients, health care providers and even the system.
In the following paragraphs, the evaluation plan will be illustrated with the proposed
outcomes, nature and numbers of clients to be evolved, strategies of measurement,
data analysis and basis for an effective change of practice.
5.1 Identifying outcomes
The primary patient outcome for evaluation would be pain score. RNs who are in
charge of the patient and participate in the venipuncture procedure would be
responsible for assessing the patient and documenting the pain score and patient’s
demographic data in the venipuncture record (Appendix 1) pain assessment, Visual
Analog Scale (VAS) and Faces Legs Activity Cry Consolability Pain Scale (FLACC)
would be used (Appendix 2). VAS was widely reviewed as a valid pain assessment
tool for children aged above 3 without developmental delay and mental illness
(Anthony & Schanberg,2007; Crellin, et.al, 2007; Garra et al., 2010; Tomlinson, et.
al., 2010). For those who aged under 3, FLACC Scale for assessing pain by five
observational behavioral components including faces, legs, activity, cry and
consolibility of patient, was proven as reliable and valid. (Crellin, et.al, 2007;
42
Tomlinson, et. al., 2010; Bai, Hsu, Tang & van Dijk, 2012; Summers, 2001; Ramelet,
Rees, Mcdonald, Bulsara, & Huijer, 2007). As the pain assessment would be done by
nurses, it is essential to ensure all nurses are able to assess pain of patient correctly
with the VAS and FLACC scale. Before starting the implementation guideline,
training sessions would be provided for nurses to revise on how to assess pain with
the pain scales and the selection of pain scale according to the age.
The secondary patient outcomes would be the success rate of venipuncture. Number
of attempts of venipuncture would be documented in the venipuncture record
(Appendix 1). As it is more difficult to perform venipuncture with a large size of
angiocatheter, size of an angiocatheter used would also be recorded.
Staff satisfaction would be evaluated as the healthcare provider outcome by an
anonymous self-reported survey (Appendix 3). All users of the implementation would
be included in the survey. A 5-point Likert scale ranging from 1 to 5 would be used.
The rating would be given from 1 representing strongly disagree to 5 representing
strongly agree. A mean score would be calculated, and the score would be
proportional to staff satisfaction. In the survey, staff was also encouraged to give
advice on the guideline and express their concerns towards the guideline. The same
survey will be distributed to the ward staff twice at one week time and one month
time after the implementation starts. At one week time, the survey provides
43
information on staff satisfaction and problems encountered for members of the
working group to solve the problems. And the survey at one month time would be
compared with the previous survey for any difference in the staff satisfaction and new
problems encountered during the implementation process.
The system outcomes would be the utilization rate of the guideline and cost of the
implementation. The utilization rate would be counted by counting the venipuncture
record. The cost of the implementation would be calculated from the account record
of material cost and maintenance cost, which are kept by the ward secretary and the
ward manager.
5.2 Timing and frequency of data measurement
For the primary and the secondary patient outcomes, they would be measured just
after venipuncture procedure. For the staff satisfaction, data would be collected at one
week time and one month time after the implementation starts. For the utilization rate
of the guideline and the cost, data would be collected right after the implementation
period.
5.3 Nature and number of clients to be involved
The inclusion and exclusion criteria of patients would be the same as the guideline
discussed before. Pediatric patients aged from 1 to 9 would be included, while those
diagnosed to have developmental delay, altered mental status and visual or auditory
44
deficits would be excluded.
Previous studies showed significant effect of the implementation on relieving pain of
children undergoing venipuncture (Bellieni et al., 2006; MacLaren & Cohen, 2005;
Tak & van Bon, 2005; Wang et al., 2008; Yoo et al., 2011). For data collection, the
design will be the same as in the pilot study. For statistical analysis, a two tailed t test
will be performed to investigate for the reduction in pain level of children. GPower
(2014) was used for calculation of the sample size of the patients. By using effect size
of 0.3 and 95% Power, the sample size was estimated to be 134. From the
Phlebotomist record of the ward, there are approximately 1000 patients aged from 1 to
9 requiring venipuncture in 2013 (Phlebotomist record, 2013), in considerations of
some patients may fulfil the exclusion criteria, approximately 2 months time was
expected to recruit 111subjects. Therefore, a 2 month implementation period would
be required.
5.4 Data analysis
After the implementation period, the data collected would be entered into a computer
database and analyzed with the Statistical Package for Social Science (SPSS) software.
Two tail t-test would be used to investigate for any reduction in the pain score in the
intervention group. Two-tailed t-test would also be used to determine whether the
number of attempts for the venipuncture would be reduced.
45
For the staff satisfaction, both data collected one week time and one month time
would be estimated with 95% confidence interval. For the utilization rate of the
implementation, 95% confidence interval would also be used
The cost would be calculated by the sum of the material cost and the miscellaneous
cost, including ink and paper for printing venipuncture record, survey, etc.
5.5 Evaluation on the effectiveness of change of practice
To consider whether the change of practice is effective, effect on reduction of pain
and times of venipuncture, staff satisfaction and utilization rate would be considered.
For the primary outcome, the reduction of pain score of children and times of
venipuncture compared to the current practice would be considered as a significant
indicator for effective change of practice. For the staff satisfaction, result from the
staff survey showing a mean score of 3 out of five of the Likert scale is considered as
supporting the implementation. For the utilization rate, it should be over 70%. With
the evaluation result available, there would be an evaluation meeting with DOM and
WM at the end of the evaluation period to discuss on the result of the data analysis
and to determine whether to continue to adopt the innovation.
46
Chapter 6: Conclusion
From the best available evidence, video distraction is reported to have moderate to
strong effect on the alleviation of pain, and also have positive effect on the reduction
of distress and successful rate of venipuncture (Bellieni et al., 2006; MacLaren &
Cohen, 2005; Tak & van Bon, 2005; Wang et al., 2008; Yoo et al., 2011). However, it
has not been implemented for the alleviation of pain of children during venipuncture
in the proposed pediatric unit, which may be due to the lack of evidence based
guideline.
The evidence based guideline in this paper was developed with the support of the best
evidence synthesized from the identified studies, and the implementation potential is
considered to be high in terms of transferability, feasibility and cost.
As venipuncture is a common procedure in the paediatric unit, that there will be a
number of paediatric patients benefited from the implementation of video distraction
during venipuncture. Hopefully the application of the implementation will also be
effective in the pain management and the reduction of distress, and the modified
guideline can become a usual pain management strategy for paediatric patients during
venipuncture in the proposed clinical setting.
47
Appendix 1
Searching process
Search Terms PubMed CINAHL British Nursing Index
1 Needle / IV access /
IV cannulation /
venipuncture/
venipuncture
124420 13308 464 (narrowed results
by subject: children:
pain = 28)
2 TV 8435 2363
3 audiovisual 7964 674
4 Visual audio 1974 289
5 cartoon 619 157
6 distraction 10939 2971
7 1+2 68 7
8 1+3 24 3
9 1+4 14 0
10 1+5 5 3
11 1+6 93 68
Studies met
selection criteria
5 3 2
48
Appendix 1
Searching the evidence
Items in appendix 1 PubMed CINAHL British Nursing Index
1. 7+8+9+10+11 204 81
2 After screening
titles and abstracts,
and removal of
duplication
8 5
(2 studies
published
in Italian)
2
After reading full
text
5 3
49
Citation Study
design
Evidence
Level
Subject
characteristics
Interventions Control Outcome measures Effect size
(Cohen’s d)
Bellieni, C.V., Cordelli,
D.M., Raffaelli, M., Ricci,
B., Morgese, G. &
Buonocore, G. (2006).
Analgesic effect of
watching TV during
venepuncture. Arch Dis
Child, 91(12), 1015–1017.
RCT
+ - Age range:
7-12
- Mean age:
8-9
- Able to use
numeric scale
TV group (n= 23)
- Age appropriate cartoon
- started 120sec before
procedure
- Mother present without
distraction
M group (n = 23)
active distraction (speaking,
caressing, soothing) by mother
n = 23
Mother
present
without
distraction
1) Pain rated by
children
2) Pain rated by
caregiver
Pain scale:
Oucher scale
1) p = 0.037
TV vs C: d = 0.77
M vs C: d = 0.25
2) p = 0.045
TV vs C: d = 0.6
M vs C: d = - 0.09
MacLaren, J. & Cohen, L.
(2005). A comparison of
Distraction Strategies for
Venipuncture Distress in
Children. Journal of
Pediatric Psychology,
30(5), 387-396.
RCT + Age range:
1-7
Mean age:
4.29 (SD=1.8)
two age
groups:
age 1-3;
age 4-7
M group (n = 29)
Cartoon or animation movie
- age 1-3: Teletubbies; age 4-7:
Toy Story 2/ The Little Mermaid
- start 5-7min before procedure
- encourage child’s adherence to
distraction
T group (n = 30) - Interactive toy
- age 1-3: toy robot with buttons
age 4-7 computer games
n = 29
Standard
care with
instruction
to
minimize
distracting
behavior
when
possible
1) Child Engagement in
distraction
2) Child distress by
caregiver-report (VAS)
3) Child distress by
nurse-report (VAS)
4) Child distress by
Self-report (faces scale)
5) Child distress by
Observation (OBSD)
M vs C:
1) p <0.01
2) P<0.01
d = 0.7
3) p = 0.367
d = 0.15
4) p < 0.01
d = 0.9
5) d = 0.5
RCT = randomized controlled trial; n = number of subject; SD = standard deviation; C = control T= toy
50
Citation Study
design
Evidence
Level
Subject
characteristics
Interventions Control Outcome measures Effect size
(Cohen’s d)
Tak, J.H. & van Bon, W.H.J.
(2005). Pain- and
distress-reducing interventions for
venepuncture in children. Child:
Care, Health & Development, 32,
3, 257–268.
RCT + Age range:
3-12
I. Placebo, Distraction,
information (n = 20)
II. ELMA, Distraction,
information (n = 21)
Distraction:
6 min fragment of video
cartoon: “ The Beauty &
The Beast”
III. Placebo,
information
(n = 20)
IV. EMLA,
information
( n = 21)
1) Behavioral distress
(Groningen Distress
Scale: breathing,
crying, muscle tone)
2) Self reported pain
Pain scale:
Age < 6: Oucher scale
Age >=6: VAS
1) T2
I vs III: d = -0.18
II vs IV: d = 0.5
2) T3
I vs III: d = 0.5
II vs IV: d = 0.09
p value not
available
Wang, Z.X. , Sun, L.H. & Chen, A.P.
(2008) The efficacy of
non-pharmacological methods of
pain management in school age
children receiving venepuncture in a
paediatric department: a randomized
controlled trial of audiovisual
distraction and routine psychological
intervention. Swiss Med Wkly, 138
(39-40), 579–584.
RCT ++ Age range:
8-9
AV group (n = 100)
- Audiovisual distraction
- 10 appropriate cartoons
- chosen by patients
- Start 3 min before
procedure
P group (n = 100)
- Psychological intervention
scheme (Explain before
procedure, therapeutic
touch, encouragement,
guided imagery)
No special
Intervention
(n = 100)
1) cooperation
2) venipuncture times
3) pain intensity
Pain scale: VAS
AV vs C
1) p = 0.064
2) p = 0.045
3) p = 0.047
d = 0.28
51
RCT = randomized controlled trial; n = number of subject; C = control; EMLA= Eutectic mixture of local anaesthetics; T2 = just before venipuncture; T3= during
venipuncture; VAS Visual Analog Scale
Citation Study design Evidence
Level
Subject
characteristics
Interventions Control Outcome measures Effect size
(Cohen’s d)
Yoo, H., Kim, S., Hur,
H.K. & Kim, H.S.
(2011). The effects of
an animation
distraction
intervention on pain
response of preschool
children during
venipuncture. Applied
Nursing Research,
24(2), 94–100.
Quasi-
experimental
0 Age range:
3-7
Experimental
group older
than control
group by 10.5
months
A group (n = 20)
3- min animation
downloaded from website
for free
Standard
care
1) self-reported pain
2) behavioral pain
response
3) blood cortisol level
4) blood glucose level
5) Heart rate
Pain scale:
1) Poker chip scale
2) Faces rating scale of
Wong and Baker (1988)
1) p = 0.029; d = 0.72
2) p = 0.002; d = 1.02
3) p = 0.043; d = 0.73
4) p = 0.003; d = 1.01
5) p = 0.809
52
S I G N
Methodology Checklist 2: Controlled Trials
Study identification (Include author, title, year of publication, journal title, pages)
Bellieni, C.V., Cordelli, D.M., Raffaelli, M., Ricci, B., Morgese, G. & Buonocore, G. (2006). Analgesic effect
of watching TV during venepuncture. Arch Dis Child, 91(12), 1015–1017.
Guideline topic: Key Question No: Reviewer:
Before completing this checklist, consider:
1. Is the paper a randomised controlled trial or a controlled clinical trial? If in doubt, check the study design algorithm available from SIGN and make sure you have the correct checklist. If it is a controlled clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+
2. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention Comparison Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.
Reason for rejection: 1. Paper not relevant to key question 2. Other reason (please specify):
SECTION 1: INTERNAL VALIDITY
In a well conducted RCT study… Does this study do it?
1.1 The study addresses an appropriate and clearly focused question.i
Yes
Can’t say
No
1.2 The assignment of subjects to treatment groups is randomised.ii
Yes
Can’t say
No
1.3 An adequate concealment method is used.iii
Yes
Can’t say
No
1.4 Subjects and investigators are kept ‘blind’ about treatment
allocation.iv
Yes
Can’t say
No
1.5 The treatment and control groups are similar at the start of the trial.v
Yes No
Can’t say
1.6 The only difference between groups is the treatment under
investigation.vi
Yes
Can’t say
No
1.7 All relevant outcomes are measured in a standard, valid and reliable
way.vii
Yes
Can’t say
No
1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was
completed?viii
0%
1.9 All the subjects are analysed in the groups to which they were
randomly allocated (often referred to as intention to treat analysis).ix
Yes
Can’t say
No
Does not apply
1.10 Where the study is carried out at more than one site, results are
comparable for all sites.x
Yes
Can’t say
No
Does not apply
SECTION 2: OVERALL ASSESSMENT OF THE STUDY
2.1 How well was the study done to minimise bias? High quality (++)
53
Code as follows:xi
Acceptable (+)
Unacceptable – reject 0
2.2 Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention?
Yes
2.3 Are the results of this study directly applicable to the patient group targeted by this guideline?
Yes
2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and the extent to which it answers your question and mention any areas of uncertainty raised above.
The study concludes that cartoon distraction has effective analgesic effect during venipuncture.
Although the sample size is small, the effect size of pain relief rated by children was high. The
intervention is applicable to children aged from 7-12.
i Unless a clear and well defined question is specified, it will be difficult to assess how well the study has met its objectives or how relevant it is to the question you are trying to answer on the basis of its conclusions.
ii Random allocation of patients to receive one or other of the treatments under investigation, or to receive either treatment or placebo, is fundamental to this type of study.
iii Allocation concealment refers to the process used to ensure that researchers are unaware which group patients are being allocated to at the time they enter the study. Research has shown that where allocation concealment is inadequate, investigators can overestimate the effect of interventions by up to 40%.
iv Blinding refers to the process whereby people are kept unaware of which treatment an individual patient has been receiving when they are assessing the outcome for that patient. It can be carried out up to three levels. Single blinding is where patients are unaware of which treatment they are receiving. In double blind studies neither the clinician nor the patient knows which treatment is being given. In very rare cases studies may be triple blinded, where neither patients, clinicians, nor those conducting the analysis are aware of which patients received which treatment. The higher the level of blinding, the lower the risk of bias in the study.
v Patients selected for inclusion in a trial must be as similar as possible. The study should report any significant differences in the composition of the study groups in relation to gender mix, age, stage of disease (if appropriate), social background, ethnic origin, or co-morbid conditions. These factors may be covered by inclusion and exclusion criteria, rather than being reported directly. Failure to address this question, or the use of inappropriate groups, should lead to the study being downgraded.
vi If some patients received additional treatment, even if of a minor nature or consisting of advice and counselling rather than a physical intervention, this treatment is a potential confounding factor that may invalidate the results. If groups were not treated equally, the study should be rejected unless no other evidence is available. If the study is used as evidence it should be treated with caution.
vii The primary outcome measures used should be clearly stated in the study. If the outcome measures are not stated, or the study bases its main conclusions on secondary outcomes, the study should be rejected. Where outcome measures require any degree of subjectivity, some evidence should be provided that the measures used are reliable and have been validated prior to their use in the study.
viii The number of patients that drop out of a study should give concern if the number is very high. Conventionally, a 20% drop out rate is regarded as acceptable, but this may vary. Some regard should be paid to why patients dropped out, as well as how many. It should be noted that the drop out rate may be expected to be higher in studies conducted over a long period of time. A higher drop out rate will normally lead to downgrading, rather than rejection of a study.
54
ix In practice, it is rarely the case that all patients allocated to the intervention group receive the intervention throughout the trial, or that all those in the comparison group do not. Patients may refuse treatment, or contra-indications arise that lead them to be switched to the other group. If the comparability of groups through randomisation is to be maintained, however, patient outcomes must be analysed according to the group to which they were originally allocated irrespective of the treatment they actually received. (This is known as intention to treat analysis.) If it is clear that analysis was not on an intention to treat basis, the study may be rejected. If there is little other evidence available, the study may be included but should be evaluated as if it were a non-randomised cohort study.
x In multi-site studies, confidence in the results should be increased if it can be shown that similar results were obtained at the different participating centres.
xi Rate the overall methodological quality of the study, using the following as a guide: High quality (++): Majority of criteria met. Little or no risk of bias. Results unlikely to be changed by further research. Acceptable (+): Most criteria met. Some flaws in the study with an associated risk of bias, Conclusions may change in the light of further studies. Low quality (0): Either most criteria not met, or significant flaws relating to key aspects of study design. Conclusions likely to change in the light of further studies
55
S I G N
Methodology Checklist 2: Controlled Trials
Study identification (Include author, title, year of publication, journal title, pages)
MacLaren, J. & Cohen, L. (2005). A comparison of Distraction Strategies for Venipuncture Distress in
Children. Journal of Pediatric Psychology, 30(5), 387-396.
Guideline topic: Key Question No: Reviewer:
Before completing this checklist, consider:
1. Is the paper a randomised controlled trial or a controlled clinical trial? If in doubt, check the study design algorithm available from SIGN and make sure you have the correct checklist. If it is a controlled clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+
2. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention Comparison Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.
Reason for rejection: 1. Paper not relevant to key question 2. Other reason (please specify):
SECTION 1: INTERNAL VALIDITY
In a well conducted RCT study… Does this study do it?
1.1 The study addresses an appropriate and clearly focused question.xi
Yes
Can’t say
No
1.2 The assignment of subjects to treatment groups is randomised.xi
Yes
Can’t say
No
1.3 An adequate concealment method is used.xi
Yes
Can’t say
No
1.4 Subjects and investigators are kept ‘blind’ about treatment
allocation.xi
Yes
Can’t say
No
1.5 The treatment and control groups are similar at the start of the trial.xi Yes
Can’t say □
No
1.6 The only difference between groups is the treatment under
investigation.xi
Yes
Can’t say
No
1.7 All relevant outcomes are measured in a standard, valid and reliable
way.xi
Yes
Can’t say
No
1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was
completed?xi
0%
1.9 All the subjects are analysed in the groups to which they were
randomly allocated (often referred to as intention to treat analysis).xi
Yes
Can’t say
No
Does not apply
1.10 Where the study is carried out at more than one site, results are
comparable for all sites.xi
Yes
Can’t say
No
Does not apply
SECTION 2: OVERALL ASSESSMENT OF THE STUDY
56
2.1 How well was the study done to minimise bias? Code as follows:xi
High quality (++)
Acceptable (+)
Unacceptable – reject 0
2.2 Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention?
Yes
2.3 Are the results of this study directly applicable to the patient group targeted by this guideline?
Yes
2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and the extent to which it answers your question and mention any areas of uncertainty raised above.
The study showed significance of cartoon distraction on reducing distress of children during
venipuncture, with large effect size. With verbal pain as one of the components of distress included in
the study, the intervention may also be effective in reducing the procedural pain of children.
57
S I G N
Methodology Checklist 2: Controlled Trials
Study identification (Include author, title, year of publication, journal title, pages)
Tak, J.H. & van Bon, W.H.J. (2005). Pain- and distress-reducing interventions for venepuncture in children.
Child: Care, Health & Development, 32, 3, 257–268.
Guideline topic: Key Question No: Reviewer:
Before completing this checklist, consider:
3. Is the paper a randomised controlled trial or a controlled clinical trial? If in doubt, check the study design algorithm available from SIGN and make sure you have the correct checklist. If it is a controlled clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+
4. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention Comparison Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.
Reason for rejection: 1. Paper not relevant to key question 2. Other reason (please specify):
SECTION 1: INTERNAL VALIDITY
In a well conducted RCT study… Does this study do it?
1.1 The study addresses an appropriate and clearly focused question.xi
Yes
Can’t say
No
1.2 The assignment of subjects to treatment groups is randomised.xi
Yes
Can’t say
No
1.3 An adequate concealment method is used.xi
Yes
Can’t say
No
1.4 Subjects and investigators are kept ‘blind’ about treatment
allocation.xi
Yes
Can’t say
No
1.5 The treatment and control groups are similar at the start of the trial.xi Yes
Can’t say □
No
1.6 The only difference between groups is the treatment under
investigation.xi
Yes
Can’t say
No
1.7 All relevant outcomes are measured in a standard, valid and reliable
way.xi
Yes
Can’t say
No
1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was
completed?xi
0%
1.9 All the subjects are analysed in the groups to which they were
randomly allocated (often referred to as intention to treat analysis).xi
Yes
Can’t say
No
Does not apply
1.10 Where the study is carried out at more than one site, results are
comparable for all sites.xi
Yes
Can’t say
No
Does not apply
SECTION 2: OVERALL ASSESSMENT OF THE STUDY
58
2.1 How well was the study done to minimise bias? Code as follows:xi
High quality (++)
Acceptable (+)
Unacceptable – reject 0
2.2 Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention?
Yes
2.3 Are the results of this study directly applicable to the patient group targeted by this guideline?
Yes
2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and the extent to which it answers your question and mention any areas of uncertainty raised above.
Comparing the effect of EMLA cream, the analgesic effect of cartoon distraction was comparatively
less significant. However, looking into the result of the study, when ELMA cream was not used,
cartoon distraction showed moderate effect on pain relief during venipuncture. As EMLA cream is
also not currently used in my clinical setting, the cartoon distraction is an effective strategy for pain
relief.
59
S I G N
Methodology Checklist 2: Controlled Trials
Study identification (Include author, title, year of publication, journal title, pages)
Wang, Z.X. , Sun, L.H. & Chen, A.P. (2008) The efficacy of non-pharmacological methods of pain
management in school age children receiving venepuncture in a paediatric department: a randomized
controlled trial of audiovisual distraction and routine psychological intervention. Swiss Med Wkly, 138
(39-40), 579–584.
Guideline topic: Key Question No: Reviewer:
Before completing this checklist, consider:
5. Is the paper a randomised controlled trial or a controlled clinical trial? If in doubt, check the study design algorithm available from SIGN and make sure you have the correct checklist. If it is a controlled clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+
6. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention Comparison Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.
Reason for rejection: 1. Paper not relevant to key question 2. Other reason (please specify):
SECTION 1: INTERNAL VALIDITY
In a well conducted RCT study… Does this study do it?
1.1 The study addresses an appropriate and clearly focused question.xi
Yes
Can’t say
No
1.2 The assignment of subjects to treatment groups is randomised.xi
Yes
Can’t say
No
1.3 An adequate concealment method is used.xi
Yes
Can’t say
No
1.4 Subjects and investigators are kept ‘blind’ about treatment
allocation.xi
Yes
Can’t say
No
1.5 The treatment and control groups are similar at the start of the trial.xi Yes
Can’t say □
No
1.6 The only difference between groups is the treatment under
investigation.xi
Yes
Can’t say
No
1.7 All relevant outcomes are measured in a standard, valid and reliable
way.xi
Yes
Can’t say
No
1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was
completed?xi
0%
1.9 All the subjects are analysed in the groups to which they were
randomly allocated (often referred to as intention to treat analysis).xi
Yes
Can’t say
No
Does not apply
1.10 Where the study is carried out at more than one site, results are
comparable for all sites.xi
Yes
Can’t say
No
Does not apply
SECTION 2: OVERALL ASSESSMENT OF THE STUDY
60
2.1 How well was the study done to minimise bias? Code as follows:xi
High quality (++)
Acceptable (+)
Unacceptable – reject 0
2.2 Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention?
Yes
2.3 Are the results of this study directly applicable to the patient group targeted by this guideline?
Yes
2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and the extent to which it answers your question and mention any areas of uncertainty raised above.
The study concludes that video distraction was effective in relieving the pain, improving patient’s
cooperation and successful rate venipuncture. It showed significance of video distraction for pain
control of children aged from 8 to 9.
61
S I G N
Methodology Checklist 2: Controlled Trials
Study identification (Include author, title, year of publication, journal title, pages)
Yoo, H., Kim, S., Hur, H.K. & Kim, H.S. (2011). The effects of an animation distraction intervention on pain
response of preschool children during venipuncture. Applied Nursing Research, 24(2), 94–100.
Guideline topic: Key Question No: Reviewer:
Before completing this checklist, consider:
7. Is the paper a randomised controlled trial or a controlled clinical trial? If in doubt, check the study design algorithm available from SIGN and make sure you have the correct checklist. If it is a controlled clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+
8. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention Comparison Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.
Reason for rejection: 1. Paper not relevant to key question 2. Other reason (please specify):
SECTION 1: INTERNAL VALIDITY
In a well conducted RCT study… Does this study do it?
1.1 The study addresses an appropriate and clearly focused question.xi
Yes
Can’t say
No
1.2 The assignment of subjects to treatment groups is randomised.xi
Yes
Can’t say
No
1.3 An adequate concealment method is used.xi
Yes
Can’t say
No
1.4 Subjects and investigators are kept ‘blind’ about treatment
allocation.xi
Yes
Can’t say
No
1.5 The treatment and control groups are similar at the start of the trial.xi Yes
Can’t say □
No
1.6 The only difference between groups is the treatment under
investigation.xi
Yes
Can’t say
No
1.7 All relevant outcomes are measured in a standard, valid and reliable
way.xi
Yes
Can’t say
No
1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was
completed?xi
0%
1.9 All the subjects are analysed in the groups to which they were
randomly allocated (often referred to as intention to treat analysis).xi
Yes
Can’t say
No
Does not apply
1.10 Where the study is carried out at more than one site, results are
comparable for all sites.xi
Yes
Can’t say
No
Does not apply
SECTION 2: OVERALL ASSESSMENT OF THE STUDY
62
2.1 How well was the study done to minimise bias? Code as follows:xi
High quality (++)
Acceptable (+)
Unacceptable – reject 0
2.2 Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention?
Yes
2.3 Are the results of this study directly applicable to the patient group targeted by this guideline?
Yes
2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and the extent to which it answers your question and mention any areas of uncertainty raised above.
The study concludes that video distraction was effective in relieving the pain, improving patient’s
cooperation and successful rate venipuncture. It showed significance of video distraction for pain
control of children aged from 8 to 9.
63
Appendix 4
Levels of Evidence
1++ High quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low risk of bias
1+ Well-conducted meta-analyses, systematic reviews, or RCTs with a low risk of bias
1- Meta-analyses, systematic reviews, or RCTs with a high risk of bias
2++ High quality systematic reviews of case control or cohort or studies
High quality case control or cohort studies with a very low risk of confounding or bias and a high
probability that the relationship is causal
2+ Well-conducted case control or cohort studies with a low risk of confounding or bias and a moderate
probability that the relationship is causal
2- Case control or cohort studies with a high risk of confounding or bias and a significant risk that the
relationship is not causal
3 Non-analytic studies, e.g. case reports, case series
4 Expert opinion
64
Appendix 5
Grades of Recommendations
A At least one meta-analysis, systematic review, or RCT rated as 1++, and directly applicable to the
target population; or
A body of evidence consisting principally of studies rated as 1+, directly applicable to the target
population, and demonstrating overall consistency of results
B A body of evidence including studies rated as 2++, directly applicable to the target population, and
demonstrating overall consistency of results; or
Extrapolated evidence from studies rated as 1++ or 1+
C A body of evidence including studies rated as 2+, directly applicable to the target population and
demonstrating overall consistency of results; or
Extrapolated evidence from studies rated as 2++
D Evidence level 3 or 4; or
Extrapolated evidence from studies rated as 2+
65
Appendix 6
Venipuncture Record
Gum Label
Please Tick the appropriate Box.
For Others, please specify.
Ethnicity: □Asian □White □Indian/Pakistanian □Others:___________
Chief Complaint: □Fever □GE □Acute Bronchiolitis □Head injury □Allergy □Others:____________
Size of Cannula: □20GA □22GA □24GA □Others:_______
Location of Cannulation: □Antecubital □Hand □Others:__________
No. of attempts of Venipuncture __________
Pain Scale: Visual Analog Scale/ FLACC Scale
Pain Score:____________/10
Adverse Events: □None □Erythema □Edema
66
Appendix 7
67
Appendix 8 Satisfactory Survey for Healthcare Providers
Please circle your answer.
Strongly
disagree
disagree neutral agree Strongly
agree
1. I think this implementation can
reduce pediatric venipuncture pain.
1 2 3 4 5
2. I think this implementation do not
place a burden to healthcare providers.
1 2 3 4 5
3. I feel comfortable in doing this
implementation
1 2 3 4 5
4. I support this implementation 1 2 3 4 5
68
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